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NCT Number: NCT07173881

Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk

Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients, and this will have consequences on the growth and development of the child. In 2021, at IDIP, a specific milk product for pregnant and lactating women, Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals, and DHA ) was designed and developed as part of a key strategy to incorporate into public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level. The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for pregnant women on maternal nutritional status and the composition of human milk at one month postpartum.

Specific objectives include:

To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not.

To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Interzonal de Agudos General San Martín, La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. "San Martín" in La Plata, and who regularly consume milk, will be included.
  • Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included.

Exclusion criteria

  • Women who have had multiple pregnancies and/or women with malabsorption diseases.

Treatment and study plan

Fortified powder milk

Dietary Supplement

Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.

Primary outcomes

  1. Breast milk DHA concentration

    Time frame: Time Frame: breast milk DHA concentration will be assessed at one month postpartum.

    Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample

  2. Mother Zinc concentration

    Time frame: Mother Zinc concentration will be assessed at one month postpartum

    Zinc concentration in mother serum expressed in mg/dl

  3. mother Vit E concentration

    Time frame: Mother's serum α-tocopherol concentration will be assessed at one month postpartum

    α-tocopherol concentration in mother serum expressed in μmol/L

  4. Mother Vit A concentration

    Time frame: Mother's Vit A concentration will be assessed at one month postpartum

    Retinol concentration in mother serum expressed in μmol/L

  5. Mother red blood cell DHA concentration

    Time frame: Mother's serum DHA concentration will be assessed at one month postpartum

    Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample

  6. Mother hemoglobin concentration

    Time frame: Mother's hemoglobin concentration will be assessed one month postpartum

    hemoglobin concentration in mother serum expressed in g/dL

  7. Breast milk Vitamin A concentration

    Time frame: Breast milk Vitamin A concentration will be assessed at one month postpartum

    Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample

  8. Breast milk Vitamin E concentration

    Time frame: Breast milk Vitamin E concentration will be assessed at one month postpartum

    α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample

  9. Breast milk Vitamin D concentration

    Time frame: Breast milk Vitamin D concentration will be assessed at one month postpartum

    25-hidroxi vitamin D concentration in breast milk expressed in ng/ml

  10. Breast milk Zinc concentration

    Time frame: Breast milk Zinc concentration will be assessed at one month postpartum

    Zinc concentration in breast milk expressed in mg/dl

  11. Breast milk Calcium concentration

    Time frame: Breast milk Calcium concentration will be assessed at one month postpartum

    Calcium concentration in breast milk expressed in mg/dl

  12. Breast milk Iron concentration

    Time frame: Breast milk Iron concentration will be assessed at one month postpartum

    Iron concentration in breast milk expressed in mg/dl

  13. Breast milk Iodine concentration

    Time frame: Breast milk Iodine concentration will be assessed at one month postpartum

    Iodine concentration in breast milk expressed in mg/dl

  14. Mother serum ferritin concentration

    Time frame: Mother's serum ferritin concentration will be assessed at one month postpartum

    ferritin concentration in mother serum expressed in ng/ml

  15. mother Vit D concentration

    Time frame: mother Vit D concentration will be assessed at one month postpartum

    25-hidroxi vitamin D concentration in mother serum expressed in ng/ml

Study contacts

Contact information is provided by the study sponsor or research team.

Maria F Andreoli, PhD

CONTACT

[email protected]

542214177324

Sponsors and collaborators

Lead sponsor

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Other

Collaborators

  • Hospital Interzonal de Agudos General San Martín

Registry information

Official study title

Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental Study in a Vulnerable Population

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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